Prospective Observational Epidemiologic Study of Maraviroc's Safety (POEM)
This study is ongoing, but not recruiting participants.
Sponsor:
ViiV Healthcare
Collaborator:
Pfizer
Information provided by (Responsible Party):
ViiV Healthcare
ClinicalTrials.gov Identifier:
NCT00665561
First received: April 23, 2008
Last updated: February 9, 2015
Last verified: February 2015
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Purpose
The study will assess if use of maraviroc along with an optimized background regimen of antiretroviral drugs in usual clinical practice is as safe as using only an optimized regimen of antiretroviral drugs.
| Condition | Intervention | Phase |
|---|---|---|
|
Human Immunodeficiency Virus |
Drug: Maraviroc along with an optimized background antiretroviral drug regimen Drug: Optimized background antiretroviral drug regimen without maraviroc |
Phase 4 |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | An International, Multicenter, Prospective Observational Study Of The Safety Of Maraviroc Used With Optimized Background Therapy In Treatment-experienced Hiv-1 Infected Patients |
Resource links provided by NLM:
Further study details as provided by ViiV Healthcare:
Primary Outcome Measures:
- CDC Category C AIDS defining infections, Viral encephalitis, Rhabdomyolysis, Liver failure, Liver related deaths [ Time Frame: Followed till 6 months after drug discontinuation up to a total of 5 years. ] [ Designated as safety issue: Yes ]
- All Malignancies (AIDS defining and non-AIDS defining), Myocardial ischemia or infarction, All cause mortality [ Time Frame: Followed for a total of up to 5 years regardless of the time of drug discontinuaion. ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- There are no Secondary Outcomes for this study. [ Time Frame: 0 ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 3000 |
| Study Start Date: | March 2008 |
| Estimated Study Completion Date: | October 2018 |
| Estimated Primary Completion Date: | October 2018 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
| Maraviroc exposed |
Drug: Maraviroc along with an optimized background antiretroviral drug regimen
Maraviroc prescribed per approved local label.
Other Name: Selzentry
|
| Maraviroc unexposed |
Drug: Optimized background antiretroviral drug regimen without maraviroc
Optimized background antiretroviral therapy prescribed per approved local label and treatment guidelines.
|
Detailed Description:
All patients meeting the study eligibility criteria at participating sites will be invited to participate.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Study Population
Treatment experienced, HIV-1 infected patients in routine clinical practice.
Criteria
Inclusion Criteria:
- Treatment experienced, HIV-1 infected patients
- 18 years or older
- Receive an approved assay for determination of HIV-1 tropism
Exclusion Criteria:
- Pregnant or lactating
- Using CCR5 inhibitor other than maraviroc
Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00665561
Show 269 Study Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00665561
Show 269 Study Locations
Sponsors and Collaborators
ViiV Healthcare
Pfizer
Investigators
| Study Director: | Pfizer CT.gov Call Center | Pfizer |
More Information
Additional Information:
No publications provided
| Responsible Party: | ViiV Healthcare |
| ClinicalTrials.gov Identifier: | NCT00665561 History of Changes |
| Other Study ID Numbers: | A4001067, 2007-006148-24, POEM |
| Study First Received: | April 23, 2008 |
| Last Updated: | February 9, 2015 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by ViiV Healthcare:
|
Maraviroc HIV-1 Safety Non-interventional |
Additional relevant MeSH terms:
|
Acquired Immunodeficiency Syndrome HIV Infections Immune System Diseases Immunologic Deficiency Syndromes Lentivirus Infections RNA Virus Infections |
Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Slow Virus Diseases Virus Diseases |
ClinicalTrials.gov processed this record on March 03, 2015